Comparative evaluation of A-prf+ or collagen membrane on hard and soft tissue changes following immediate implant placement- A randomised clinical trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 1. SOFT TISSUE THICKNESS
研究概览
简要总结
**AIM :**The aim of this present study is to compare the clinical efficacy of A-PRF+ and collagen membrane after immediate implant placement and to evaluate the hard and soft tissue changes around the implant site. **OBJECTIVES :**To evaluate and compare clinical parameters viz. Gingival Index(GI), Plaque Index(PI), Width of Keratinized Tissue(WKT), Midbuccal & Midlingual/Midpalatal soft tissue thickness and ISQ values at baseline and 3 months in Group I (Immediate implant placement & A-PRF+) and Group II (Immediate implant placement & Collagen Membrane). To evaluate and compare crestal bone levels using CBCT at baseline and 3 months in Group I (Immediate implant placement & A-PRF+) and Group II (Immediate implant placement & Collagen Membrane). Immediate implant is a highly reliable option for replacement for teeth as it shortens the overall treatment time and also preserves the bone architecture. Following immediate implant placement there will be some amount of bone loss owing to remodeling. So, using biomaterials like A-PRF+ and collagen membrane during IIP may be helpful in decreasing the bone resorption around the implant. A-PRF+ and collagen membrane may also enhances the soft tissue volume around the implant. A-PRF+ being autologous product may be preferred over xenogenic collagen membrane if results are in favour of A-PRF+.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects aged between 18- 60 years.
- •Patient with adequate oral hygiene status.
- •No active periodontal disease.
- •Patients requiring the replacement of one or more non-restorable teeth with sufficient bone volume will be selected for the study.
- •Patient willing to give informed consent.
- •Patients with good compliance so as to meet the follow-up.
排除标准
- •Patient with systemic disease.
- •Patient with autoimmune disease, psychiatric disorder , osteoporosis.
- •Patient undergoing or who underwent radiation therapy and chemotherapy to the head and neck region during the last 12 months.
- •Patient with poor oral hygiene.
- •Alcoholics , drug abusers or heavy smokers.
- •Pregnant or lactating women.
结局指标
主要结局
1. SOFT TISSUE THICKNESS
时间窗: Baseline to 3 months
Midbuccal and Midlingual/Midpalatal soft tissue thickness will be measured 3mm from the gingival crest margin using endodontic K-File with stopper. Standardization achieved using indented acrylic stent. The soft tissue thickness on endodontic K-file will be measured using digital vernier caliper.
时间窗: Baseline to 3 months
2. WIDTH OF KERATINIZED TISSUE
时间窗: Baseline to 3 months
will be measured using UNC 15 periodontal probe, using a standardized acrylic stent.
时间窗: Baseline to 3 months
3. RADIOGRAPHIC PARAMETERS
时间窗: Baseline to 3 months
Crestal bone levels will be measured with CBCT using acrylic stent with gutta percha point for standardization before implant placement (baseline) and after 3 months postoperatively.
时间窗: Baseline to 3 months
次要结局
- 1. Implant Stability Quotient (ISQ) :(ISQ will be measured using RFA (Penguin®) immediately after implant placement and at 3 months after implant placement.)
研究者
Dr Raagul S
ITS CDSR